Chest Pain
Conditions
Keywords
chest pain, coronary artery disease, CAD
Brief summary
A prospective multicenter imaging study for evaluation of chest pain. Objective is to determine whether an initial non-invasive anatomic imaging strategy with coronary CT angiography (CTA) will improve clinical outcomes in subjects with symptoms concerning for coronary artery disease relative to an initial functional testing strategy (usual care). Study hypothesis: initial anatomic testing strategy will provide information that will result in superior long-term health outcomes as compared to an initial functional testing strategy.
Detailed description
Pragmatic randomized trial of clinical effectiveness of diagnostic testing strategies for coronary artery disease (CAD), to be performed in outpatient settings including acute and primary care and cardiology offices. Qualifying patients presenting with new or worsening symptoms suspicious for clinically significant CAD who require diagnostic testing and have not been previously evaluated will be randomized to an initial strategy of either anatomic or functional testing. All subsequent decisions regarding additional testing, medications and/or procedures will be at the discretion of the responsible clinical care team Within the functional testing arm, the subject's care team will select the specific test to be performed (exercise electrocardiogram (ECG), stress nuclear, or stress echocardiogram (echo)) consistent with 'usual care' in that practice setting. The subject's care team will be provided with 'Information sheets' summarizing current standards for test interpretation and preventive care, but specific medical treatment will not be mandated by the trial.
Interventions
PROCEDURECoronary Angiography
Use of standard equipment for usual-care testing
PROCEDUREStress Echocardiogram
Use of standard equipment for usual-care testing
PROCEDURENuclear Stress Test
Use of standard equipment for usual-care testing
PROCEDUREExercise Electrocardiogram
Use of standard equipment for usual-care testing
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* new or worsening chest pain suspicious for clinically significant coronary artery disease (CAD) * no prior evaluation for this episode of symptoms * planned non-invasive testing for diagnosis * men age ≥55 years * men age ≥45 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented \>50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented \> 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than \<0.9, 4-Dyslipidemia * women age ≥65 years * women age ≥50 years with increased probability of coronary artery disease (CAD) due to either (A. Diabetes Mellitus (DM) requiring medical treatment OR Peripheral Arterial Disease (PAD) defined as documented \>50% peripheral arterial stenosis treated medically or invasively OR cerebrovascular disease (stroke, documented \> 50% carotid stenosis treated medically or invasively) OR B. At least one of the following cardiovascular risk factors: 1-Ongoing tobacco use, 2-Hypertension, 3-Abnormal ankle brachial index (ABI) defined as less than \<0.9, 4-Dyslipidemia * Serum creatinine ≤ 1.5 mg/dL within the past 90 days * Negative urine/serum pregnancy test for female subjects of child-bearing potential
Exclusion criteria
* Diagnosed or suspected acute coronary syndrome (ACS) requiring hospitalization or urgent or emergent testing; Elevated troponin or creatine kinase-myocardial band (CK-MB) * Hemodynamically or clinically unstable condition systolic blood pressure (BP) \< 90 mmHg, atrial or ventricular arrhythmias, or persistent resting chest pain felt to be ischemic despite adequate therapy) * Known coronary artery disease (CAD) with prior Myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or any angiographic evidence of coronary artery disease (CAD) ≥50% lesion in a major epicardial vessel * Any invasive coronary angiography or non-invasive anatomic or functional cardiovascular (CV) test for detection of coronary artery disease (CAD), including coronary tomographic angiography (CTA) and exercise electrocardiogram (ECG), within the previous twelve (12) months * Known significant congenital, valvular (\> moderate) or cardiomyopathic process (hypertrophic cardiomyopathy or reduced systolic left ventricular function (LVEF) ≤ 40%)) which could explain cardiac symptoms * Contraindication to undergoing a coronary tomographic angiography (CTA), including but not limited to: a. Allergy to iodinated contrast agent, b. Unable to receive beta blockers unless heart rate \< 65 beats per minute, c. Pregnancy * Life expectancy \< 2 years * Unable to provide written informed consent or participate in long-term follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Primary Endpoint | 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months | Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Death or Myocardial Infarction (MI) | 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months | Time to this secondary endpoint as defined as a composite of death and myocardial infarction (MI). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups. |
| Time to Major Complications From Cardiovascular (CV) Procedures | 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months | Time to this secondary endpoint as defined as a composite of major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups. |
| Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months | Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, unstable angina hospitalization, and no coronary artery disease (CAD). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups. |
| Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization | Up to 90 days following participant randomization | Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease (CAD)Within 90 Days Following Participant Randomization |
| Medical Cost | 90 days and 3 years cumulative | Assess and compare total medical cost for the two diagnostic testing arms by intention to treat at both 90 days and 3 years cumulative. |
| Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months | Time to this secondary endpoint as defined as a composite of death, myocardial infarction (MI), and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups. |
| Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale | Baseline, 6 month, 12 month, 24 month | Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships. |
| Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale | Baseline, 6 months, 12 months, 24 months | Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships. |
| Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing | 6 month, 12 month 24 month | Percentage of participants with improvement in Quality of Life as measured by complete resolution of the symptoms that led to initial testing |
| Cumulative Radiation Exposure Within 90 Days | 90 days | Cumulative radiation exposure from all cardiovascular diagnostic tests and procedures performed within 90 days after randomization. |
| Quality of Life (QOL) as Measured by Duke Activity Status Index | Baseline, 6 months, 12 months 24 months | Participant score in Quality of Life as measured by Duke Activity Status Index (DASI). DASI measures a person's functional capacity based on a 12-item questionnaire that correlates with peak O2 uptake during exercise testing. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Functional Diagnostic Tests Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram
Stress Echocardiogram: Use of standard equipment for usual-care testing
Nuclear Stress Test: Use of standard equipment for usual-care testing
Exercise Electrocardiogram: Use of standard equipment for usual-care testing | 5,007 |
| Anatomic Diagnostic Test Coronary Angiography
Coronary Angiography: Use of standard equipment for usual-care testing | 4,996 |
| Total | 10,003 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 75 | 74 |
| Overall Study | Lost to Follow-up | 652 | 510 |
| Overall Study | Withdrawal by Subject | 543 | 289 |
Baseline characteristics
| Characteristic | Functional Diagnostic Tests | Anatomic Diagnostic Test | Total |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 8.3 | 60.7 years STANDARD_DEVIATION 8.3 | 60.8 years STANDARD_DEVIATION 8.3 |
| Sex: Female, Male Female | 2675 Participants | 2595 Participants | 5270 Participants |
| Sex: Female, Male Male | 2332 Participants | 2401 Participants | 4733 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 5,007 | 37 / 4,996 |
| serious Total, serious adverse events | 161 / 5,007 | 168 / 4,996 |
Outcome results
Primary
Time to Primary Endpoint
Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Time frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anatomic Diagnostic Test | Time to Primary Endpoint | 90 days | 1.0 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Primary Endpoint | 6 months | 1.2 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Primary Endpoint | 12 months | 1.8 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Primary Endpoint | 18 months | 2.5 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Primary Endpoint | 24 months | 2.9 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Primary Endpoint | 30 months | 3.5 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Primary Endpoint | 36 months | 4.6 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Primary Endpoint | 42 months | 5.3 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Primary Endpoint | 42 months | 5.1 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Primary Endpoint | 90 days | 1.1 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Primary Endpoint | 24 months | 2.8 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Primary Endpoint | 6 months | 1.4 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Primary Endpoint | 36 months | 3.8 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Primary Endpoint | 12 months | 1.9 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Primary Endpoint | 30 months | 3.5 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Primary Endpoint | 18 months | 2.6 Percentage of participants with an event |
Secondary
Cumulative Radiation Exposure Within 90 Days
Cumulative radiation exposure from all cardiovascular diagnostic tests and procedures performed within 90 days after randomization.
Time frame: 90 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Anatomic Diagnostic Test | Cumulative Radiation Exposure Within 90 Days | 10.0 milliSievert (mSv) |
| Functional Diagnostic Tests | Cumulative Radiation Exposure Within 90 Days | 11.3 milliSievert (mSv) |
Secondary
Medical Cost
Assess and compare total medical cost for the two diagnostic testing arms by intention to treat at both 90 days and 3 years cumulative.
Time frame: 90 days and 3 years cumulative
Population: Patients enrolled in PROMISE and cared for in the fee-for-service sector of the US health care system were included in the economic study. Because the costing methods being used were not applicable to other health systems, patients enrolled in the Military/VA system , an Health maintenance Organization (HMO) , or in Canada were excluded.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Anatomic Diagnostic Test | Medical Cost | 90 days | 2494 Per participant cost in US dollars |
| Anatomic Diagnostic Test | Medical Cost | 3 years cumulative | 7213 Per participant cost in US dollars |
| Functional Diagnostic Tests | Medical Cost | 90 days | 2240 Per participant cost in US dollars |
| Functional Diagnostic Tests | Medical Cost | 3 years cumulative | 6586 Per participant cost in US dollars |
Secondary
Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization
Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease (CAD)Within 90 Days Following Participant Randomization
Time frame: Up to 90 days following participant randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anatomic Diagnostic Test | Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization | 3.4 Percentage of events | Standard Error 0.3 |
| Functional Diagnostic Tests | Percentage of Invasive Cardiac Catheterization Events Without Obstructive Coronary Artery Disease Within 90 Days Following Participant Randomization | 4.3 Percentage of events | Standard Error 0.3 |
Secondary
Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing
Percentage of participants with improvement in Quality of Life as measured by complete resolution of the symptoms that led to initial testing
Time frame: 6 month, 12 month 24 month
Population: The number of participants were limited due to budget constraints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anatomic Diagnostic Test | Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing | 6 months | 43.3 % of participants |
| Anatomic Diagnostic Test | Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing | 12 months | 47.3 % of participants |
| Anatomic Diagnostic Test | Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing | 24 months | 52.1 % of participants |
| Functional Diagnostic Tests | Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing | 6 months | 46.5 % of participants |
| Functional Diagnostic Tests | Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing | 12 months | 48.8 % of participants |
| Functional Diagnostic Tests | Quality of Life (QOL) as Measured by Complete Resolution of Symptoms That Led to the Initial Testing | 24 months | 54.3 % of participants |
Secondary
Quality of Life (QOL) as Measured by Duke Activity Status Index
Participant score in Quality of Life as measured by Duke Activity Status Index (DASI). DASI measures a person's functional capacity based on a 12-item questionnaire that correlates with peak O2 uptake during exercise testing. The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).
Time frame: Baseline, 6 months, 12 months 24 months
Population: The number of participants were limited due to budget constraints.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Anatomic Diagnostic Test | Quality of Life (QOL) as Measured by Duke Activity Status Index | Baseline | 21.5 participant score |
| Anatomic Diagnostic Test | Quality of Life (QOL) as Measured by Duke Activity Status Index | 12 months | 29.2 participant score |
| Anatomic Diagnostic Test | Quality of Life (QOL) as Measured by Duke Activity Status Index | 6 months | 30.5 participant score |
| Anatomic Diagnostic Test | Quality of Life (QOL) as Measured by Duke Activity Status Index | 24 months | 31.5 participant score |
| Functional Diagnostic Tests | Quality of Life (QOL) as Measured by Duke Activity Status Index | 24 months | 31.2 participant score |
| Functional Diagnostic Tests | Quality of Life (QOL) as Measured by Duke Activity Status Index | Baseline | 22.9 participant score |
| Functional Diagnostic Tests | Quality of Life (QOL) as Measured by Duke Activity Status Index | 6 months | 30.2 participant score |
| Functional Diagnostic Tests | Quality of Life (QOL) as Measured by Duke Activity Status Index | 12 months | 31.2 participant score |
Secondary
Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale
Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.
Time frame: Baseline, 6 months, 12 months, 24 months
Population: The number of participants were limited due to budget constraints.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Anatomic Diagnostic Test | Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale | Baseline | 58.3 participant score |
| Anatomic Diagnostic Test | Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale | 6 month | 83.3 participant score |
| Anatomic Diagnostic Test | Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale | 12 month | 83.3 participant score |
| Anatomic Diagnostic Test | Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale | 24 month | 91.7 participant score |
| Functional Diagnostic Tests | Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale | 24 month | 91.7 participant score |
| Functional Diagnostic Tests | Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale | Baseline | 58.3 participant score |
| Functional Diagnostic Tests | Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale | 12 month | 91.7 participant score |
| Functional Diagnostic Tests | Quality of Life (QOL) as Measured by Seattle Anginal Quality of Life Subscale | 6 month | 83.3 participant score |
Secondary
Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale
Participant score Quality of Life measured by Seattle Angina Scale Anginal Frequency Subscale utilizing the Seattle Angina Questionnaire (SAQ). SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether symptoms are changing. Anginal Frequency: how often patient having symptoms Physical Limitation: how much condition hampers ability to do what he wants.Treatment Satisfaction: how well patient understands care. Disease Perception: impact of condition on interpersonal relationships. Each dimension assigns response an value, beginning with 1 for response at the lowest level of functioning & summing across items within each of the 5 scales. Scale scores transformed to 0-100 range by subtracting the lowest scale. Higher score suggest symptoms more stable & less frequent, condition has less impact on activities, increased satisfaction with treatment, & perception of disease has less impact on interpersonal relationships.
Time frame: Baseline, 6 month, 12 month, 24 month
Population: The number of participants were limited due to budget constraints.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Anatomic Diagnostic Test | Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale | Baseline | 70 participant score |
| Anatomic Diagnostic Test | Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale | 6 month | 100 participant score |
| Anatomic Diagnostic Test | Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale | 12 month | 100 participant score |
| Anatomic Diagnostic Test | Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale | 24 month | 100 participant score |
| Functional Diagnostic Tests | Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale | 24 month | 100 participant score |
| Functional Diagnostic Tests | Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale | Baseline | 80 participant score |
| Functional Diagnostic Tests | Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale | 12 month | 100 participant score |
| Functional Diagnostic Tests | Quality of Life (QOL) as Measured by Seattle Angina Scale Anginal Frequency Subscale | 6 month | 100 participant score |
Secondary
Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization
Time to this secondary endpoint as defined as a composite of death, myocardial infarction (MI), and unstable angina hospitalization. The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Time frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 90 day | 0.9 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 6 month | 1.2 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 12 month | 1.8 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 18 month | 2.5 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 24 month | 2.9 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 30 month | 3.5 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 36 month | 4.6 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 42 month | 5.2 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 42 month | 5.1 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 90 day | 1.0 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 24 month | 2.8 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 6 month | 1.4 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 36 month | 3.7 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 12 month | 1.9 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 30 month | 3.4 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina Hospitalization | 18 month | 2.5 Percentage of participants with an event |
Secondary
Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD)
Time to primary endpoint as defined as a composite of death, myocardial infarction (MI), major complications from cardiovascular (CV) procedures or testing, unstable angina hospitalization, and no coronary artery disease (CAD). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Time frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 90 days | 4.4 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 6 months | 4.6 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 12 months | 5.2 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 18 months | 5.9 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 24 months | 6.3 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 30 months | 6.9 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 36 months | 8.0 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 42 months | 8.7 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 42 months | 9.1 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 90 days | 5.2 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 24 months | 6.9 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 6 months | 5.6 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 36 months | 7.9 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 12 months | 6.1 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 30 months | 7.6 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death, Myocardial Infarction (MI), Unstable Angina (UA), Complications, No Coronary Artery Disease (CAD) | 18 months | 6.7 Percentage of participants with an event |
Secondary
Time to Death or Myocardial Infarction (MI)
Time to this secondary endpoint as defined as a composite of death and myocardial infarction (MI). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Time frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anatomic Diagnostic Test | Time to Death or Myocardial Infarction (MI) | 24 months | 1.7 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death or Myocardial Infarction (MI) | 90 Days | 0.3 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death or Myocardial Infarction (MI) | 30 months | 2.2 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death or Myocardial Infarction (MI) | 12 months | 0.8 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death or Myocardial Infarction (MI) | 36 months | 3.3 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death or Myocardial Infarction (MI) | 6 months | 0.4 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death or Myocardial Infarction (MI) | 42 months | 3.9 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Death or Myocardial Infarction (MI) | 18 months | 1.3 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death or Myocardial Infarction (MI) | 42 months | 4.2 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death or Myocardial Infarction (MI) | 90 Days | 0.6 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death or Myocardial Infarction (MI) | 6 months | 0.9 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death or Myocardial Infarction (MI) | 12 months | 1.2 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death or Myocardial Infarction (MI) | 24 months | 2.0 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death or Myocardial Infarction (MI) | 30 months | 2.7 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death or Myocardial Infarction (MI) | 36 months | 3.0 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Death or Myocardial Infarction (MI) | 18 months | 1.8 Percentage of participants with an event |
Secondary
Time to Major Complications From Cardiovascular (CV) Procedures
Time to this secondary endpoint as defined as a composite of major complications from cardiovascular procedures and testing (stroke, bleeding, anaphylaxis, renal failure). The Kaplan-Meier events rates (cumulative percentage of participants with an event) were estimated for the anatomic and functional diagnostic test groups.
Time frame: 90 days, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anatomic Diagnostic Test | Time to Major Complications From Cardiovascular (CV) Procedures | 90 day | 0.1 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Major Complications From Cardiovascular (CV) Procedures | 12 month | 0.5 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Major Complications From Cardiovascular (CV) Procedures | 30 month | 1.7 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Major Complications From Cardiovascular (CV) Procedures | 6 month | 0.2 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Major Complications From Cardiovascular (CV) Procedures | 36 month | 2.6 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Major Complications From Cardiovascular (CV) Procedures | 18 month | 1.0 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Major Complications From Cardiovascular (CV) Procedures | 42 month | 3.1 Percentage of participants with an event |
| Anatomic Diagnostic Test | Time to Major Complications From Cardiovascular (CV) Procedures | 24 month | 1.2 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Major Complications From Cardiovascular (CV) Procedures | 42 month | 3.2 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Major Complications From Cardiovascular (CV) Procedures | 90 day | 0.3 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Major Complications From Cardiovascular (CV) Procedures | 6 month | 0.5 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Major Complications From Cardiovascular (CV) Procedures | 12 month | 0.8 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Major Complications From Cardiovascular (CV) Procedures | 18 month | 1.1 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Major Complications From Cardiovascular (CV) Procedures | 24 month | 1.4 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Major Complications From Cardiovascular (CV) Procedures | 30 month | 1.9 Percentage of participants with an event |
| Functional Diagnostic Tests | Time to Major Complications From Cardiovascular (CV) Procedures | 36 month | 2.2 Percentage of participants with an event |